In-vitro diagnostic device using external information in conjunction with test results

ABSTRACT

A system and method for augmenting or adding to the information used by an in-vitro diagnostic or other diagnostic device to generate results of a test is disclosed. A diagnostic device is capable of generating test results based on a sample, such as a sample provided by a patient, and is also capable of receiving additional information to enhance the results providable by the device. For example, an in-vitro diagnostic device is configured to read a lateral flow assay test, and is configured to receive additional diagnostic, network, test identification, or environmental information over a network. Using both the result of the diagnostic test and the additional information, the disclosed device provides more thorough, accurate, and reliable diagnostic information. The results generated by the device may be communicated to an appropriate remote device to enhance the results obtainable by such tests.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 13/229,292, filed on Sep. 9, 2011, entitled “IN-VITRO DIAGNOSTICDEVICE USING EXTERNAL INFORMATION IN CONJUNCTION WITH TEST RESULTS,” thecontents of which are hereby incorporated by reference herein.

BACKGROUND

Presently available in-vitro diagnostic (IVD) devices are used invarious medical settings to detect the presence of numerous types ofbiological conditions, such as the presence of infection antibodies,quickly and reliably. Known IVD devices are used in hospitals, clinics,doctors' offices, and other patient care facilities to enable rapiddetection and identification of potentially harmful conditions inpatients presenting at these facilities.

One type of IVD device is configured to read or otherwise analyzelateral flow assays, which can test for a wide variety of medical andenvironmental conditions or compounds. For example, lateral flow testscan rely on a form of immunoassay in which the test sample flows along asolid substrate via capillary action. Known IVD devices can read lateralflow assay strips to detect the existence of a hormone, metabolite,toxin, or pathogen-derived antigen. This reading can be accomplishedwith the use of an imager, such as a CMOS imager or a CCD-based imagingdevice, which is configured to detect the presence or absence of a lineon the lateral flow assay based on the presence or absence of a visualline on the assay. Some tests, implemented by IVD devices, are designedto make a quantitative determination, but in many circumstances thetests are designed to return or indicate a positive/negative qualitativeindication. Examples of assays that enable such qualitative analysisinclude blood typing, most types of urinalysis, pregnancy tests, andAIDS tests.

Certain known IVD devices (including known assay test strip readerdevices) are configured to report, store, and/or transmit diagnosticinformation determined solely resulting from a diagnostic test and notprovided by a source external to the IVD device. That is, certain knownIVD devices are configured to report, store, or transmit informationrelated to the infection or other condition tested for, as well as toreport, store, or transmit additional information manually entered bypatient care personnel assisting in the use of the IVD devices. Some IVDdevices are provided as stand-alone devices—that is, they performinfection detection by autonomously following a pre-programmeddecision-making process or rule. For each test performed by such an IVDdevice, the same process is undertaken, and a result is generated in thesame way. Moreover, in known IVD devices, a built-in or integrateddisplay is used to display the results of the test, and the results mayalso be printed using a built-in or attached printer.

Many known IVD devices are not configured to send or receive data to orfrom any source external to the IVD device. In such devices, the onlyoutput enabled by the IVD devices is to display the results of a test onan integrated display. Certain other known IVD devices are configured toexchange data with another device, remote from the IVD device, through ashort-range wired or wireless connection. For example, known IVD devicesmay exchange data with another device through a USB, serial, orproprietary wired connection, or through a Bluetooth, Wireless USB, orproprietary wireless connection. Finally, certain known IVD devices areconfigured to connect to a local area network (e.g., LAN) through awired (e.g., Ethernet) or wireless (e.g., WiFi or ZigBee) connection.

Known IVD devices suffer from many drawbacks. First, known IVD devicessuffer from drawbacks in that any data used by known IVD devices togenerate outcomes or test results must either be determined by thedevice as a part of the analysis of the test results, or must bemanually entered by medical personnel or other users of the IVD device.This manual entry is frequently limited, and involves the use of akeyboard or a barcode scanner. Even if such data is manually entered,known IVD devices suffer from drawbacks in that the correctness of theentered data is questionable, and in fact may be in jeopardy, dependingupon the mechanism for entering data and/or the care given to thecorrect entry of data by the user of the IVD device. Finally, known IVDdevices suffer from drawbacks in that they are limited to receiving andutilizing only that data and/or information known to the individualentering the information into the device. Other information (such asinformation obtainable from medical or other databases or informationrepositories, or from a device manufacturer) is not available for use bythe IVD device in generating its results.

Further, known IVD devices suffer from drawbacks in that the limitedconnectivity options provided with such IVD devices prevents the devicesfrom forming ad-hoc networks and connecting directly to other IVDdevices or network elements. To the extent that network capabilities areprovided, data generated by IVD devices is limited to transmissionwithin a given patient care facility. Moreover, a patient care facilitywhich enables connection of IVD devices to a network must operate anappropriate LAN or other network, and must provide infrastructure forintegrating and maintaining IVD devices within the network, both ofwhich can be costly endeavors. Finally, even with known network-enabledIVD devices, manual interaction is required to access the test resultsgenerated by an IVD device and to store it electronically in anappropriate medical facility database. For example, manual interventionis required in known IVD devices to upload data indicative of an outcomeof a diagnostic test from an IVD device and store it in an appropriateHospital Information System (HIS) or Laboratory Information System (LIS)database.

Known IVD devices do not provide a mechanism to enable near-patienttesting results to be provided to a centralized server for analysis,aggregation, and distribution using an established public network, suchas a public telephone network. Moreover, known IVD devices do notprovide a mechanism by which a centralized server can track, manage, anddetermine characteristics of those IVD devices to ensure appropriate useof the devices and appropriate use of environmental data detected by theIVD devices.

Thus, it is desirable to create IVD devices that are configured toreceive and store data from sources external to the individualsutilizing the IVD devices, in addition to data currently gathered byknown IVD devices, and to utilize the data received from externalsources to supplement the analysis capabilities of the IVD device, suchas by confirming or verifying part of the diagnostic informationgenerated by the IVD device. It is further desirable to create IVDdevices that are network-ready, such that the devices can connect to anetwork (such as the Internet) and obtain external data independent fromthe actual test being performed. It is also desirable to create an IVDdevice that is capable of sending or uploading data to a remoterepository via a network, such that data about the tests performed withsuch IVD devices can be stored and analyzed, alone or in the aggregate,by remote devices or personnel. Finally, it is desirable to provide anIVD device that includes a built-in mechanism for accessing publiclyavailable networks, such as telephone or cellular networks, to enabledirect communication by the IVD device with network elements or otherIVD devices to enable electronic test result transmission, storage,analysis and/or dissemination without requiring separate intervention oraction by the user of the IVD device.

SUMMARY

The present disclosure relates to a system, method, and apparatus forproviding enhanced results of known diagnostic tests by augmenting theinformation used to generate the results of such tests.

The disclosed system facilitates the transmission of informationfollowing the collection of that information in diagnostic examination,such as diagnostic information collected using diagnostic instruments ortests. The disclosed system advantageously focuses on the transmissionof information to individuals that most need that information, asopposed to simply focusing on the collection of that information. Forexample, when one or more diagnostic tests are performed outside of alaboratory or other medical environment, the disclosed system enablesthe transmission of the results of those diagnostic tests to devicesand/or users that consume the data, such as by analyzing or storing thedata in a database.

Furthermore, the disclosed system advantageously enables laboratoriesand other medical facilities that lack the requisite informationtransmission infrastructure to transmit data to appropriate, necessaryconsumers. Thus, for example, if a relatively rural laboratory orfacility does not contain network infrastructure, the disclosed systemnonetheless enables that laboratory or facility to transmit informationto an end-user for analysis, storage, or other consumption. In variousembodiments, discussed below, the disclosed system enables thisfunctionality by relying on publicly accessible, established datatransmission networks, such as cellular telephone networks.

In various embodiments, however, the disclosed system facilitatestransmission of results from a testing site (such as from a testingdevice) to a private, centralized server. The server may then distributethe information it has received as appropriate, such as by distributingthe information to testing centers, primary care physicians,individuals, insurance companies, or other appropriate recipients of thedata. In one embodiment, the centralized server performs at least someaggregation and/or analysis of the data prior to distribution. Forexample, if a patient has a cardio-monitor in his or her home, the datafrom the cardio-monitor may be transmitted to the server via a publiccellular infrastructure, and the central server may then aggregate thedata for submission to the individual's primary care physician once aweek.

In some embodiments, the server performs additional functions. Forexample, the server may apply rules to data, may encrypt and/or decryptdata, may track transmitting devices (including the environmentalconditions of those transmitting devices), may maintain a registry ofdevices, and may perform other tasks as appropriate and as discussed inmore detail below.

For example, in a known in-vitro diagnostic (IVD) device, the instantdisclosure relates to a mechanism by which the standard, conventionaltest results are enhanced or expanded by providing the IVD device withadditional information or data from which to determine test results, orto store in association with the test results to enable in-depthanalysis of the test results. This additional information may beautomatically received from a network or other external source, and maybe used to aid in confirmation and verification of the diagnosticinformation generated by the IVD device. In the event the data isreceived from a network or external source, the IVD device in oneembodiment may include a device, such as a cellular modem, to enable theIVD device to connect with a publicly available and publicly maintaineddata network, such as a public telephone or cellular network.Alternatively or in addition, diagnostic test data obtained by the IVDdevice can be tagged with hardware and/or environmental information toenable accurate analysis and aggregation of data based on testsperformed with or by the IVD device. For example, the diagnostic testdata can be tagged with device quality data, device lifetime data,environmental temperature data, and the like.

In an embodiment of the disclosed system, a diagnostic data generationdevice, such as an IVD device, is configured to generate a test resultor other diagnostic data based on a biological sample. For example, anIVD device is configured to analyze the results of a lateral flow assaytest by analyzing whether certain reactions occur along the length of alateral flow assay test strip when the strip is brought into contactwith a biological sample. In addition to the biological sample (and thedata obtainable therefrom), the disclosed IVD device is configured toreceive additional information, from which additional conclusions and/oranalyses can be drawn with regard to the test. Examples of thisadditional information usable by an IVD device as disclosed hereininclude diagnostic information specific to the IVD device or the testitself, network information relating to the network to which the IVDdevice is connected, environmental data about the environment in whichthe IVD device was created, stored, or used, or other suitableadditional information to enable augmentation of the test resultsgenerated by the IVD device.

In one embodiment, the additional information is provided automatically(i.e., without a user of the IVD device requesting it) via a networkconnection. In one such embodiment, each IVD device includes a device,such as a cellular modem, for accessing a publicly provided, publiclymaintained data network. The publicly provided network could be a publictelephone network, a public cellular network, or another suitable kindof publicly available data network. In one embodiment, the disclosed IVDdevice is configured to receive additional information via a network,such as a Local Area Network or a cellular network, and is furtherconfigured to use this additional information to generate further ormore detailed test results. This additional information may relate tothe specifics of the network to which the IVD device is connected (e.g.,the IP address of the IVD device on the network), or may relate tospecific characteristics of the IVD device on which the diagnostic datawas generated (e.g., the storage temperature of the IVD device).Alternatively, the additional information usable by the IVD device toaugment or enhance its test results may be input by the user of the IVDdevice and/or by a health care professional or other individual remotefrom the IVD device.

Upon receiving the additional information, the IVD device of oneembodiment is configured to utilize the received information incombination with the diagnostic information generated by the IVD deviceitself. Hardware and environmental information may be used to ensurequality and integrity of the diagnostic test result. For example, theIVD device may utilize data about the temperature at which it was storedto validate or confirm the results of the performed diagnostic test.Alternatively or in addition, the disclosed IVD device may upload orotherwise provide both the data indicative of the diagnostic test resultand the additional information to a remote network element, such as aHospital Information System (HIS), a Laboratory Information System(LIS), or over an ad-hoc network to another IVD device for aggregationand further analysis, as discussed in detail below. This sharing of datavia publicly maintained data networks enables known IVD devices toprovide accurate results, enables the disclosed system to performanalyses on aggregations of real-time data from a plurality of IVDdevices, enables IVD devices to be calibrated on-the-fly, and enablestests themselves to be calibrated or enhanced based on real-timeresults, thus advantageously enhancing the effectiveness of testsenabled by such IVD devices and the utility of data generated by suchIVD devices.

It should thus be appreciated that one embodiment of the disclosedsystem and methods enable IVD devices to obtain and utilize independentand additional data to further augment the results of tests performed bythe IVD devices. This additional data may be external to the test itselfand/or to the facility at which the test is performed, and may beprovided to the IVD device via a network or based on the environment ofthe IVD device. The external data may be advantageously used for manypurposes, including complementing or confirming the diagnosticinformation generated by the IVD device.

It should be further appreciated that one embodiment of the disclosedsystem and methods enable IVD devices to connect to certain networkinfrastructure elements over one or more publicly provided datanetworks, such as a cellular network, using a built-in connectiondevice. Such network connectivity enables IVD devices to automaticallycommunicate diagnostic test data, as well as additional data determinedby the IVD device itself or via the connection to the data network, tocertain network elements for aggregation, analysis, and reporting. Thisaugmented set of data further enables IVD devices themselves, as well ascriteria and protocols for performing tests, to be updated on-the-fly,and enables real-time analysis of large sets of IVD data.

Additional features and advantages are described herein, and will beapparent from, the following Detailed Description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a flow chart of an example process for providing an in-vitrodiagnostic (IVD) device with additional information for use ingenerating results of a test, as disclosed herein.

FIG. 1B is a flow chart of an alternative example process for providingan in-vitro diagnostic device with additional information via a networkconnection for use in generating results of a test, as disclosed herein.

FIG. 1C is a flow chart of an alternative example process for testresults from an in-vitro diagnostic device and for providing additionalinformation via a network connection for use in correlating the testresults with other test results based on a characteristic of thein-vitro diagnostic device.

FIG. 2 illustrates a schematic block diagram of an example data network,to which a disclosed IVD device can connect, which enables the IVDdevice to communicate data obtained as a result of a diagnostic testand/or automatically obtained data in addition to the diagnostic testdata, with various remote network elements, for aggregation, analysis,reporting, and feedback generation, as disclosed herein.

DETAILED DESCRIPTION

The present disclosure relates generally to in-vitro diagnostic (IVD)devices, the information made available to such IVD devices, and theresults generated by such IVD devices. More particularly, one embodimentof the present disclosure relates to IVD devices which are configured todetermine a results of a diagnostic test, such as a diagnostic testperformed on a biological sample using a lateral flow assay test strip.In this embodiment, an IVD device is configured to receive additionalinformation beyond the information obtainable by analyzing thebiological sample (e.g., beyond the determination that one or more lineswas displayed on a lateral flow assay), such as by receiving additionalinput from a user or by receiving additional information over a network,and to use this additional information to determine an additional resultof the diagnostic test. Another embodiment of the present disclosurerelates to IVD devices that are configured to communicate with remotedevices, such as other IVD devices or other remote network elements anddata repositories, to exchange data with the remote devices forenhancing the results otherwise determinable by the IVD devices. In afurther embodiment, the IVD device includes a network access device,such as a cellular modem or other appropriate access device, whichenables the IVD device to access a public data network such as a publictelephone or cellular network. In this embodiment, certain additionaldata may be obtained through the data network, and the disclosed IVDdevice may automatically upload diagnostic data and any determinedadditional data to a remote network element via the data network, asdescribed in detail below.

The instant disclosure is applicable in the context of IVD devicesgenerally, many different kinds of which are known in the art. Forexample, the instant disclosure is applicable to IVD devices that areconfigured to read lateral flow assay test strips, such as by detectingthe presence or absence of visible or other lines on the assay teststrips following application of a biological sample to the assay teststrip. The instant disclosure is also applicable in the context of IVDdevices that analyze the results of reactions occurring in a test tubeor other controlled environment, in which a biological sample such as abodily fluid reacts with a reagent or other substance to generate achemical reaction. While at various points throughout this disclosureassay test strip reader IVD devices are discussed, it should beappreciated that any suitable IVD device, such as IVD devices frequentlyused in hospitals, clinics, doctors' offices, or other patient carefacilities for rapid detection of various infections, can equally makeuse of the concepts disclosed herein.

In one embodiment of the disclosed system, an IVD device is configuredto determine an outcome of a diagnostic test in much the same way aswith conventional IVD devices. That is, the IVD device is configured todetermine an outcome of a diagnostic test by analyzing a biological orother kind of sample (or a reaction therewith) applied to the IVDdevice. In this embodiment, however, the IVD device is configured toperform or enable additional analysis to be performed beyond thediagnostic test. That is, the IVD device is configured to receiveadditional information or data, which additional information or data canbe combined with the results determined by the IVD device based on thebiological sample, to generate an additional or augmented result of thediagnostic test. In one embodiment, this additional or augmented resultincludes a result which confirms or verifies part of the result of thediagnostic test determined by the IVD device's analysis of thebiological sample. This additional data, as well as the additionalresults enabled thereby, are discussed in detail below.

In another embodiment, the disclosed IVD device is configured to connectto one or more existing networks to facilitate the exchange ofinformation between the IVD device and a remote device, such as a remoteIVD device or some other kind of remote network resource. In an exampleof this embodiment, an IVD device is equipped with one or more devices,such as a cellular modem, to enable connection with remote networkelements over publicly accessible networks, such as a public telephonenetwork or a cellular network. Such an IVD device may thus communicateover the existing network without relying on intermediate, short-rangelinks or connections, such as Bluetooth, UART, USB, WiFi, Wireless USB,ZigBee, or the like.

By enabling connection via existing networks as described, oneembodiment of the disclosed IVD device enables the transmission,storage, dissemination, and analysis of electronic test results andother data related to the IVD devices without requiring a user tophysically connect the IVD device to a suitable network hub or element.In one embodiment, the disclosed IVD device is configured tocommunicate, via the disclosed network, in a wireless fashion, without ashort-range link, in a two-way fashion with at least one networkelement.

In still another embodiment, the disclosed IVD device is configured bothto determine an additional or augmented test result and to communicatewith one or more remote network devices over an existing network. Inthis embodiment, an IVD device enables a user to perform a diagnostictest, as described, and thereafter to communicate via an existingnetwork with a remote device, such as a remote IVD device or anotherremote network resource. Over the communication link established usingthe existing network, the IVD device receives information usable todetermine the additional or augmented test result. In one embodiment,the additional or augmented test result is determined by the IVD deviceupon the IVD device receiving additional information. In anotherembodiment, the additional or augmented test result is determined by aremote network element, such as a remote IVD device or a remote server,upon the IVD device sending the diagnostic information determined basedon the biological sample to the remote network element.

In one embodiment, the additional result enabled by the disclosed IVDdevices includes a confirmation or verification of the results of adiagnostic test performed by the IVD device. For example, informationobtained by the IVD device may confirm that at a given operatingcondition, a designated raw data result (e.g., a designated detectedvoltage) corresponds with the determined result of the diagnostic test.In another embodiment, the additional result enabled by the disclosedIVD devices includes storage of certain data, such as environmentaldata, in association with a particular test result. This storage of datain association with a test result enables the disclosed IVD device (or anetwork element to which the IVD device transmits data) to constructaggregate analyses or reports of data from a plurality of differentdiagnostic tests.

FIG. 1A illustrates a flow chart of a process 100 for operating an IVDdevice according to one embodiment disclosed herein. Although theexample process 100 is described with reference to the flow chartillustrated in FIG. 1A, it should be appreciated that many otherprocesses of operating an IVD device are contemplated. For example, theorder of certain of the steps of process 100 may be changed, and certainof the steps of process 100 are optional.

According to FIG. 1A, an IVD device is operated by first receiving abiological sample in the IVD device, as indicated by block 102. Forexample, if the IVD device is a device configured to read a lateral flowassay strip, the process 100 may include receiving a biological sample,such as urine or another bodily fluid, on an appropriate assay teststrip. Upon receiving the biological sample, the disclosed IVD devicedetermines a first test result based on the received biological sample,as indicated by block 104. For example, if a bodily fluid was applied toa lateral flow assay test strip, the IVD device may determine a resultof the diagnostic test, such as whether a person who provided a urinesample is pregnant, by analyzing whether certain lines or other physicalindicia are present on the lateral flow assay test strip followingapplication of the biological sample thereto. It should be appreciatedthat determining the first test result could be performed according toany one of a number of known diagnostic tests enabled by known IVDdevices.

After the IVD device determines the first test result, as indicated byblock 104, the IVD device receives additional information, as indicatedby block 106. This additional information may be diagnostic information,network information, hardware information, environmental information, orother appropriate additional information as described herein. Using boththe additional information and the first test result previouslydetermined by the IVD device, the IVD device determines a second testresult, as indicated by block 108. For example, if the first test resultincludes diagnostic information, the IVD device may use the additionalinformation in conjunction with the first test result to verify orconfirm the diagnostic information represented by the first test result.

FIG. 1B illustrates a flow chart of an alternate process 150 foroperating an IVD device according to one embodiment disclosed herein.Although the example process 150 is described with reference to the flowchart illustrated in FIG. 1B, it should be appreciated that many otherprocesses of operating an IVD device are contemplated. For example, theorder of certain of the steps of process 150 may be changed, and certainof the steps of process 150 are optional.

According to FIG. 1B, as in FIG. 1A, an IVD device is operated by firstreceiving a biological sample in the IVD device, as indicated by block152. Upon receiving the biological sample, the disclosed IVD devicedetermines a first test result based on the received biological sample,as indicated by block 154.

In the process 150 illustrated in FIG. 1B, the IVD device thenestablishes a network connection with an external information source.For example, the IVD device may establish a network connection over apublic telephone or cellular network using a built-in cellular modem orother network access device. The IVD device may then establish such aconnection with a remote IVD device, a remote server, or another remotenetwork element or resource. Upon establishing the connection, the IVDdevice receives additional information from the external informationsource, as indicated by block 158. For example, if the IVD deviceestablishes a connection with a remote database accessible from a remoteserver via a network connection, the IVD device receives informationfrom the database, which information is usable to further analyze theresults of the diagnostic test. Finally, the IVD device determines asecond test result based both on the first test result and theadditional information received from the external information source, asindicated by block 160. As described above with respect to FIG. 1A, anexample of this determination may include a verification of the firsttest result using information obtained from a remote network resource,such as from a remote server or from a remote IVD device.

According to FIG. 1C, as in FIG. 1B, an IVD device is operated accordingto process 200 by first receiving a biological sample in the IVD device,as indicated by block 170. Upon receiving the biological sample, thedisclosed IVD device determines a first test result based on thereceived biological sample, as indicated by block 172. The IVD devicethen establishes a network connection with an external informationsource, as indicated by block 174. For example, the IVD device mayestablish a network connection over a public telephone or cellularnetwork using a built-in cellular modem or other network access device.The IVD device may then establish such a connection with a remote IVDdevice, a remote server, or another remote network element or resource.Upon establishing the connection, the IVD device provides its testresults to a database server, as further indicated by block 174.Finally, as illustrated in block 176 the database server correlates thetest data with other test data based on spatial, temporal, or othercorrelation factors.

In various embodiments, the disclosed IVD device is configured togenerate or otherwise access diagnostic information for use during thediagnostic test. In one embodiment, diagnostic information (that is, theinformation obtained by the IVD device directly) is inherent to the IVDdevice, determined during the course of a test, or manually entered bypatient care personnel through the use of a keyboard, barcode scanner,or other input device. Examples of this diagnostic information includethe serial number of an IVD device (such as programmed by a devicemanufacturer), the date and/or time of a test (which can be manuallyentered or provided by a real-time clock of the IVD device), thelocation of the test (such as the name of the patient care facility atwhich the test was performed), a patient identifier associated with thepatient, the test type (such as the type of infection tested for), thetest result (e.g., positive or negative), the diagnosis as determined bythe patient care personnel, the prescribed treatment or medication asdetermined by the patient care personnel, and any other additional testor patient information pertinent to the test performed by the IVDdevice.

In one embodiment, the disclosed IVD device is configured to receiveinformation in addition to diagnostic information, which additionalinformation is usable to generate the additional result. For example,the IVD device may receive additional diagnostic information from aremote device via a network connection, or may receive additionaldiagnostic information from a user of the IVD device. If the user of theIVD device provides the additional diagnostic information, theinformation may be input to the IVD device via a keyboard, a barcodescanner, or another suitable input device.

In one embodiment, an IVD device is configured to receive additionalinformation that is independent of and external to the IVD deviceitself. For example, this additional information may be networkinformation, hardware information, or environmental information, whichin one embodiment complements the diagnostic information obtained by theIVD device.

In one embodiment, the disclosed IVD device is configured to utilizenetwork information in conjunction with the diagnostic information toaugment or otherwise enhance the results of the diagnostic testperformed by the IVD device. In various embodiments, this networkinformation includes the subscriber number of the IVD device (such as anidentification number assigned to the IVD device by a public network onwhich the IVD device is communicating), the date and time of the test(as determined by the public network based on the date and time ofconnection to the network), the geographical location of the test (asdetermined by the location of the IVD device at the time of connectionor communication over the network), the IP address of the IVD device onthe network, or other information pertinent to the network on which theIVD device is communicating.

In one embodiment, the disclosed IVD device is configured to utilizehardware or environmental information in conjunction with the diagnosticinformation and/or the network information to augment or otherwiseenhance the results of the diagnostic test provided by the IVD device.In various embodiments, this hardware or environmental data includesdevice quality data, calibration date and data, environmentaltemperature, humidity, or other characteristics (during manufacture,storage, or the test itself), or other suitable hardware andenvironmental data.

In various embodiments, the disclosed IVD device is configured tocombine certain determined additional data with the results of the testdetermined by the IVD device to augment or enhance the test resultsgenerated by the IVD device. For example, the IVD device in oneembodiment combines the results of a test (e.g., a determination aboutthe presence of certain visible lines on an assay test strip) withadditional data (e.g., configuration data) to determine a more preciseresult of the test enabled by the IVD device. For instance, if thepresence of a line on an assay test strip indicates the presence orabsence of a condition, and the intensity of the line indicates theseverity of the condition, the calibration data received by the IVDdevice may enable the IVD device to make a determination as to theintensity of the line, and thus the severity of the condition, whereas aprior art IVD device may have only been able to determine the presenceof the line. Thus, it should be appreciated that in one embodiment, thedisclosed IVD device enables augmentation of test results to determinemore detailed, useful, or complete results than were previouslypossible.

In another embodiment, the IVD device combines the additional data withthe test results determined by the IVD device and enables storage,reporting, transmission, or other analysis of the combined results. Forexample, if the disclosed IVD device is configured to analyze an assaytest strip, the time and/or date may be stored in association with aparticular test, and thereafter communicated via a network connection toa remote repository, to enable further analysis of the test result/timeand date combination. Such an IVD device may enable analysis of thedevelopment of a condition over time, wherein if a first result occurson a first day and a different second result occurs on a second dayfollowing the first day, the difference in test results can becorrelated with a passage of time and can thus be utilized to track theprogression of a condition.

In one embodiment, the disclosed IVD device advantageously enables thecollection of and association of test results with additional data whichdoes not need to be input by the patient, medical care professional, orother user of the IVD device itself. It should be appreciated that thiscapability both reduces the burden on the user of the IVD device andalso increases the reliability of the data collected and relied on bythe IVD device.

In another embodiment, wherein the disclosed IVD device is configured tocreate an ad-hoc network with another IVD device, the system enables anon-functional IVD device to provide valid and usable test results evenin the absence of correct functioning. For example, if a first,non-working IVD device is capable of determining data indicative of aresult of a test (e.g., a voltage detected by a sensor when positionedadjacent to an assay test strip) but is not capable of determining whatthat voltage means, the voltage itself can be provided to another,functional IVD device via an ad-hoc network connection with thatfunctional IVD device. Upon providing the data, the functional IVDdevice can analyze the data and send its analysis back to thenon-functional IVD device, or can upload and store the data in a remoterepository, such as a network server. Thus, the disclosed system enablesIVD devices to create ad-hoc networks to ensure proper functionality asmuch of the time as possible.

In one embodiment, data collected by the IVD device can be seen as beingtagged with external data which is automatically determined, and whichdoes not depend on an operator for entry. For example, diagnostic testdata determined by an IVD device can be seen as being tagged withhardware and/or environmental information, such as device quality data,device lifetime data, environmental condition data, and the like. Thus,the disclosed IVD devices may obtain and utilize independent andexternal data, in addition to data generated by the IVD device as a partof the diagnostic test and/or information provided by a user of the IVDdevice, from a network source, based on the IVD device's hardware,and/or from its environment. This network, hardware, and environmentaldata may complement, confirm, or enhance the diagnostic data captured bythe IVD device.

In various embodiments, the disclosed IVD device is configured tocommunicate with another device (either another IVD device or a networkelement such as a remote server) via an appropriate network. In one suchembodiment, the disclosed IVD device is configured to communicate via apublic telephone network, a public cellular network, or a globalpositioning system (GPS). As discussed above, the network through whichthe IVD device communicates may provide certain information which iscombined with the diagnostic information, such as information about thegeographical location of the IVD device or information about the dateand time of the test. The network connection may also be an appropriatetelemetric connection as is described in detail below.

In various embodiments, one or more IVD devices are equipped with adevice to enable a telemetric connection over one or more publiclyaccessible or available networks. In such embodiments, IVD devices arenot limited to being standalone devices, capable only of displaying dataon local display devices, and are not limited to devices which must bespecially coupled with the remote facility to which they will connect.Rather, IVD devices equipped with a device to enable telemetricconnections advantageously enable such IVD devices to communicate testresults and other data directly to a facility outside the point of carefacility, enable the IVD devices to link directly with other IVDdevices, enable the easy integration of IVD devices without concern forthe capabilities of a specific network of IVD devices, and enableautomatic uploading and sharing of data with a Hospital InformationSystem (HIS), Laboratory Information System (LIS), or other suitablenetwork-accessible repository. It should be appreciated that through theuse of openly accessible, standardized, and globally available networks,the disclosed system enables the automatic transmission of electronictest result information, as well as the storage, analysis, anddissemination of such information, in a form transparent to the user andwithout requiring any user interaction.

In various embodiments, the disclosed system enables one or more IVDdevices to communicate with a remote device, such as another IVD deviceor a remote network element, via one or more publicly implemented andmaintained networks. In one embodiment, an IVD device configured to socommunicate over a network connection includes a network access device,such as a cellular modem, to facilitate such access. In variousembodiments, the disclosed system may enable communication over publicnetworks such as 2G, 3G, or beyond 3G public cellular networks, mayoperate under CDMA, W-CDMA, GSM, IMT-2000, PCS, or other cellularcommunication protocols, or may communicate over another suitablepublicly accessible network.

Referring now to FIG. 2, a schematic illustration of one networkedembodiment of the disclosed system 200 is illustrated. In theillustrated embodiment, arrows between certain devices and either thePublic Wide Area Network (WAN) 220 or the Public Network 230 indicatethat such devices are configured to engage in two-way communication viasuch a network. For example, if a network element illustrated in FIG. 2is associated with an arrow pointing to the network element and thePublic Network 230, that device is configured to both send data toanother device via the Public Network 230 and to receive data fromanother device via the Public Network 230.

FIG. 2 illustrates an example schematic representation of a patient carefacility 202. The patient care facility 202 illustrated in FIG. 2 mayrepresent a patient facility, such as a hospital, doctor's office, orclinic, at which one or more diagnostic tests is applied or given to apatient. In the illustrated embodiment, the patient care facility 202 isshown as including or encompassing a Hospital Information System (HIS)or Laboratory Information System (LIS) database 203. That is, in theillustrated embodiment, the patient care facility 202 maintains orotherwise provides access to an HIS or LIS database 203. In theillustrated embodiment, the HIS or LIS database 203 is a repository fortest results, summary reports, or other data related to patientsutilizing the patient care facility 202. In various embodiments, the HISor LIS database 203 is additionally coupled with one or more processors(not shown) for performing certain processing tasks, such as analysis ofdata stored in the HIS or LIS database 203.

In the illustrated embodiment, the patent care facility 202 alsoincludes a plurality of IVD devices 204 a, 204 b, and 204 c. In oneembodiment, the IVD devices are diagnostic test devices, such as devicesfor reading assay test strips, that are configured to determinediagnostic test result information based on a provided biologicalsample. It should be appreciated that any suitable IVD device could beadvantageously used concurrently with the disclosed system.

As further illustrated in FIG. 2, each IVD device 204 a, 204 b, and 204c includes a network communication device 205 a, 205 b, or 205 c,respectively. For example, the network communication devices 205 a, 205b, and 205 c could be cellular modems or other devices configured tocommunicate with a public network such as the Public Wide Area Network220 or the Public Network 230. In one embodiment, the networkcommunication devices 205 a, 205 b, and 205 c enable the respective IVDdevices to communicate with either one another, or with another networkelement, as disclosed herein. In addition, in one embodiment, thenetwork communication devices 205 a, 205 b, and 205 c enable therespective IVD devices to communicate data indicative of diagnostic testresults to remote resources, such as the HIS or LIS database 203 forstorage and/or further analysis.

The system 200 of FIG. 2 indicates, by arrow 221, that the patient carefacility 202 (and the IVD devices/HIS or LIS database contained therein)are configured to communicate via Public Wide Area Network 220. In oneembodiment, one or more of the Public Wide Area Network 220 and thePublic Network 230 limits, at least in part, access to the network.Moreover, in one embodiment, the disclosed system 200 enablescommunication between the patient care facility by encrypted or othersecure data transmission protocols, as described below.

System 200 also includes a patient computer 206, health agency computer208, insurance provider computer 210, and device manufacturer computer212. Each of these network elements are able to communicate with oneanother and with the patient care facility 202 via the Public Wide AreaNetwork 220, as indicated by arrows 222, 223, 224, and 225,respectively. Arrow 226 indicates that the Public Wide Area Network 220can communicate with a Public Network 220 of another type, such as theInternet. Thus, the devices illustrated in FIG. 2 are configured tocommunicate with one another either via Public Wide Area Network 220,Public Network 230, or some combination thereof

In the illustrated embodiment, each of the computers enables a differentparty to communicate with the device manufacturer server 212 and the IVDdevices 204 a, 204 b, 204 c and HIS or LIS database 203 containedtherein. For example, the patient computer 206 enables patients tocommunicate with the device manufacturer computer 212, the health agencycomputer 208 enables one or more health agencies to communicate with thepatient care facility 202, the insurance provider computer 210 enablesan insurance provider to communicate with the patient care facility 202,and the device manufacturer computer 212 enables the manufacturer of theIVD devices to communicate with the patient care facility 202. It shouldbe appreciated that in the illustrated embodiment, the devicemanufacturer computer 212 enables the IVD devices 204 a, 204 b, and 204c to communicate with a data server 212 a coupled to the devicemanufacturer computer 212 to, among other things, receive necessarydata, such as calibration data, firmware, or other software and dataupgrades, when the need arises.

In various embodiments, the network 200 of FIG. 2 enables thetransmission and exchange of data including test results and additionaldata sent along with the test results. For example, the data transmittedamong the various network elements of the system 200 could includediagnostic data and information, network information, hardwareinformation, and environmental information as described above. In oneembodiment, some or all of the data transmitted among the variouselements of the illustrated system 200 are encrypted to prevent unwantedaccess to the transmitted data. In addition to protecting the data frominterception and unwanted consumption, this encryption may also validateor maintain the integrity of the transmitted data, such as by providinga checksum or other mechanism to ensure that all transmitted data wasreceived.

In one embodiment, the patient computer 206, health agency computer 208,insurance provider computer 210, and device manufacturer computer 212are standard desktop or laptop computers accessible by the appropriateparty. In another embodiment, one or more of the patient computer 206,health agency computer 208, insurance provider computer 210, and devicemanufacturer computer 212 are mainframe or server computers configuredto handle large quantities of data and/or to provide complex processingand analysis routines. In this embodiment, the appropriate entity whichis responsible for the illustrated computer device (e.g., the insurancecompany responsible for the insurance provider computer) can access someor all of the data uploaded from the IVD devices and stored within thesystem, depending on the purpose of the user's access. For example, aninsurance company may access certain test data to verify that aparticular insured individual does in fact have the ailment for which aclaim was filed, or to verify that treatment for an ailment is ongoing.It should be appreciated that in various embodiments, entities otherthan those of the illustrated network elements in FIG. 2 may be able toaccess the data uploaded by the IVD devices as necessary to performthose entities' respective tasks.

In another embodiment, one or more of the patient computer 206, healthagency computer 208, insurance provider computer 210, and devicemanufacturer computer 212 are portable computers, such as personaldigital assistants (PDAs) or cellular telephones, which are configuredto enable users to access data from a handheld, portable device. In suchembodiments, the processing capabilities of the portable devices may besomewhat limited; as a result, portable devices may be primarilyintended to enable users to access data as opposed to performing complexprocessing, reporting, or other analysis on the data. In one embodiment,not shown, one or more medical professionals such as health carepersonnel staffing the patient care facility 202 access datacommunicated by the IVD devices 204 a, 204 b, or 204 c using anappropriate handheld device, such as a PDA, cellular telephone, or otherhandheld, portable device. In this embodiment, appropriate health carepersonnel can have access to, or be actively made aware of, patient dataimmediately upon the patient subjecting himself or herself to adiagnostic test using an IVD device.

The network architecture illustrated in FIG. 2 enables IVD devices totransmit, store, analyze, and disseminate electronic test results andsummaries over known and already-implemented publicly accessiblenetworks. Moreover, in instances in which analysis to be performed iseither dependent upon data in the aggregate (i.e., from a plurality ofIVD devices), or is too processor-intensive to be performed in anindividual IVD device, the disclosed system enables IVD devices totransmit appropriate data to a central location, such as an HIS or LISdatabase, and enables relatively powerful processors at the centrallocation to efficiently process and analyze the data. Finally, thedisclosed system, as illustrated in FIG. 2, enables software updates tobe pushed out to IVD devices from a device manufacturer, such as bypushing the software updates over a publicly available network, so thatIVD devices can constantly be up-to-date and can be updated asappropriate.

Moreover, by relying on a publicly available network to communicatedata, the disclosed system enables IVD devices to communicate data in amanner transparent to the user. For example, an IVD device mayautomatically transmit data, including the results of a diagnostic testand any additional data appropriate for the test, to a remote networkelement by automatically establishing a connection with the publiclyaccessible network and by automatically communicating the appropriateinformation to the remote location. In various embodiments, suchcommunication enables IVD devices to communicate test results and otherdata to a network database server and/or to other IVD devices, formingan ad-hoc network of IVD devices. In another embodiment, the datacommunicated from an IVD device can be automatically communicated to anappropriate handheld destination, such as an appropriate handheld deviceof a medical professional or other health care personnel.

In one embodiment, as discussed above, an IVD device is configured toupload data to one or more database servers. In this embodiment, thedatabase servers may be configured to archive test results, aggregatetest results into summary reports, or analyze test results for spatial,temporal, or other correlations. These database servers may additionallybe configured to perform other analyses on the data, as appropriate,depending upon the type of data uploaded and the goals of the partiesmanaging and implementing the database servers. These database serversmay, in various embodiments, be maintained by device manufacturersresponsible for manufacture of the IVD devices. In these embodiments,the database servers may correspond to device manufacturer computers 212in FIG. 2.

The ability of IVD devices to upload data directly to database serversresults in a number of advantages of the disclosed system. First,patient care facilities can obtain test results from database serversthrough secure Internet or other network connections and store theretrieved results in their own databases (e.g., their own HIS or LISdatabases). Thus, the installation effort for a patient care facilitycan be reduced to setting up hardware and software internal to thepatient care facility to facilitate access of the database server. Inaddition, the aggregated test reports available due to the processing ofthe database servers are of value to public health agencies like theCDC, FDA, and WHO. Such reports can be provided in real-time due to theability of the disclosed IVD devices to directly and automaticallycommunicate diagnostic test result data to database servers.

The ability of IVD devices to connect directly to database serversthrough a publicly available network also advantageously enablesspatial, temporal, or other correlations determined within the test datato improve the specificity of test results. For example, a databaseserver in one embodiment determines one or more correlations within thetest data, and can develop or refine a detection algorithm based on thecorrelations. Due to the network connectivity of the IVD devices, thedatabase server can thereafter push or download the refined algorithm tothe IVD devices, as appropriate.

Manufacturers or maintainers of IVD devices can also use the informationsent by the IVD devices to database servers to monitor and maintain thehealth and functionality of the IVD devices. If an IVD device ismalfunctioning, the manufacturer can schedule service, download softwareto remedy the problem, or otherwise deal with the identified problem.The manufacturer or entity responsible for maintain IVD devices can alsosend control information or data to the various IVD devices to enablethose devices to be controlled in a desired way. In addition, theability of IVD devices to connect to a database server via a publiclyavailable network enables manufacturers to improve the field service andremote diagnosis capabilities of the IVD devices and to manage theinventory and customer base of the IVD devices.

In one embodiment, IVD devices are equipped with the capability of beingremotely administrated. For example, if a large number of user errorsare detected while performing a particular test by a remoteadministrator, the disclosed IVD devices can display warning messagesand/or lock users from performing one or more functions, including fromperforming that particular test. Alternatively or in addition, remoteadministration may be performed on the IVD devices to perform qualitycontrol operations. That is, remote administration may track theoutcomes of tests, including user errors occurring while performingtests. Various actions, including displaying warning messages, updatingIVD devices, or locking users from performing certain functionalities onthe IVD devices, may be taken remotely as is appropriate.

Interoperability among the database servers and other elements of thenetwork (including HIS and LIS databases) also enables the networkelements to communicate with one another and obtain test informationreceived by each other in real-time. This ability offers the distinctadvantage of interoperability among custom database systems throughsoftware configuration.

As discussed above, in some embodiments the disclosed IVD devices cancommunicate with one another via the publicly accessible networkdisclosed herein. In some embodiments, this communication between IVDdevices is referred to as the creation of ad-hoc networks of IVDdevices. For example, multiple IVD devices can exchange test results toexplore correlations therebetween, and can appropriately notify patientcare personnel of unlikely or outlier results. Among otherfunctionalities, the ability to detect aberrations in data collected byvarious IVD devices enables medical personnel to quickly and accuratelyverify test results, verify proper usage of the IVD device, ascertainwhether an IVD device is still functioning properly, determine whetheran IVD device has malfunctioned, and/or determine whether an IVD devicehas reached the end of its operable life.

As noted above, the disclosed system is further advantageous in that itenables IVD devices to automatically and instantly send results of teststo PDAs, cellular telephones, portable computers, or other handheld ornon-handheld devices which are constantly or nearly constantly monitoredby medical personnel. In this way, the disclosed system enables patientcare personnel to obtain instant notification as test results becomeavailable, and to react with treatment or other appropriate action in atimely fashion.

It should be understood by those skilled in the art that variousmodifications, combinations, sub-combinations and alterations may occurdepending on design requirements and other factors insofar as they arewithin the scope of the appended claims or the equivalents thereof.

The invention is claimed as follows:
 1. A diagnostic test analysissystem comprising an in vitro-diagnostic device, the in vitro-diagnosticdevice comprising: at least one processor; at least one display device;at least one input device; and at least one memory device which stores aplurality of instructions which, when executed by the at least oneprocessor, cause the at least one processor to operate with the at leastone input device and the at least one display device to: enable a localuser of a diagnostic test to provide a biological sample, determine afirst result of the diagnostic test based on the biological sample, thefirst result indicating at least the presence or absence of a condition,receive a set of additional data via a network connection, the set ofadditional data indicative of a characteristic of the diagnostic testnot determinable based on the biological sample; alter the first resultof the diagnostic test based, at least in part, on the additional data,to generate an altered first result, the altered first result having animproved accuracy relative to the first result of the diagnostic test,and display the altered first result of the diagnostic test to the localuser.
 2. The diagnostic test analysis system of claim 1, wherein theplurality of instructions cause the at least one processor to alter thefirst result of the diagnostic test by re-calibrating the diagnostictest based on the received set of additional data.
 3. The diagnostictest analysis system of claim 2, wherein the received set of additionaldata comprises configuration data, and wherein the plurality ofinstructions cause the at least one processor to determine the alteredfirst result as a more precise result than the first result based on theconfiguration data.
 4. The diagnostic test analysis system of claim 1,further comprising a sensor positioned to optically detect a change in acharacteristic of an assay test device, wherein the plurality ofinstructions cause the at least one processor to determine the firstresult of the diagnostic test based on data from the sensor indicatingthe change in the characteristic of the assay test device.
 5. Thediagnostic test analysis system of claim 1, further comprising a sensorpositioned to detect the presence or absence of one or more lines on alateral flow assay test strip following application of the biologicalsample to the lateral flow assay test strip, wherein the plurality ofinstructions cause the at least one processor to determine the firstresult of the diagnostic test based on data from the sensor indicatingthe presence of absence of the one or more lines.
 6. The diagnostic testanalysis system of claim 5, wherein the received set of additional datacomprises calibration data, and wherein the plurality of instructionscause the at least one processor to use the calibration data to:determine an intensity of the one or more lines; and alter the firstresult of the diagnostic test based on the determined intensity.
 7. Thediagnostic test analysis system of claim 6, wherein the plurality ofinstructions cause the at least one processor to determine a severity ofa condition based on the intensity of the one or more lines.
 8. Thediagnostic test analysis system of claim 1, further comprising at leastone network communication device configured to provide the networkconnection by enabling a telemetric connection over a publiclyaccessible network.
 9. The diagnostic test analysis system of claim 8,wherein the plurality of instructions cause the at least one processorto automatically transmit the altered test result to a remote networkelement via the telemetric connection.
 10. The diagnostic test analysissystem of claim 8, wherein the publicly accessible network is a cellulardata network, and wherein the at least one network communication deviceincludes a cellular modem.
 11. The diagnostic test analysis system ofclaim 1, wherein the set of additional data comprises hardware data orenvironmental data associated with the in vitro-diagnostic device.
 12. Adiagnostic test analysis method comprising: receiving data from a sensorwithin a patient care facility positioned to detect the presence orabsence of one or more lines on a lateral flow assay test stripfollowing application of a biological sample to the lateral flow assaytest strip; determining a first result of a diagnostic test associatedwith the sensor based on data from the sensor indicating the presence orabsence of the one or more lines; receiving a set of additional data viaa network connection, the additional data comprising hardware data orenvironmental data associated with the patient care facility andindicative of a characteristic of the diagnostic test not determinablebased on the data from the sensor; altering the first result of thediagnostic test based, at least in part, on the additional data, togenerate an altered first result, the altered first result having animproved accuracy relative to the first result of the diagnostic test,and outputting the altered first result of the diagnostic test fordisplay to a user.
 13. The diagnostic test analysis method of claim 12,performed by at least one processor in communication with at least onememory device storing a plurality of instructions which, when executedby the at least one processor, cause the at least one processor toperform the method.
 14. The diagnostic test analysis method of claim 12,further comprising altering the first result of the diagnostic test byre-calibrating the diagnostic test based on the additional data.
 15. Thediagnostic test analysis method of claim 12, further comprisingcombining the additional data with the first result to generate thealtered first result.
 16. The diagnostic test analysis method of claim12, further comprising: determining an intensity of the one or morelines; and altering the first result of the diagnostic test based on thedetermined intensity.
 17. The diagnostic test analysis method of claim16, further comprising determining a severity of a condition based onthe intensity of the one or more lines.
 18. The diagnostic test analysismethod of claim 17, wherein the determining the first result comprisesdetermining a presence of the condition based on a presence of the oneor more lines, and wherein the altered test result comprises theseverity of the condition.
 19. The diagnostic test analysis method ofclaim 12, further comprising automatically transmitting the altered testresult to a remote network element via a telemetric connection.
 20. Thediagnostic test analysis method of claim 12, further comprisingreceiving the additional data automatically without a request from theuser.
 21. The diagnostic test analysis method of claim 12, wherein an invitro-diagnostic device comprises the sensor and wherein the first testresult comprises a voltage detected by the sensor, the method furthercomprising: providing the voltage to another device in an ad-hoc networkwith the in vitro-diagnostic device; receiving the additional data as ananalysis of the voltage from the another device; and determining thealtered first result as a valid test result in the absence of correctfunctioning of the in vitro-diagnostic device.